Kornimate/medical-research-clean huggingface dataset:
more sleep: pain response to longer sleep

Conditions: Sleep; Pain

Summary: this study is being done to find out whether extending sleep for at least an hour per night, seven days a week, predicts a higher tolerance and a higher threshold for pain. this is a 21-day study. participants will be asked to wear sleep- and heart- monitoring watches. pressure pain and cold pain will be measured at study visits.


Eligibility criteria:
inclusion criteria: 1. 18 to 24 (inclusive) years of age at enrollment 2. fluent english speaker and reader 3. willing to refrain from initiating new therapeutic interventions (e.g., medication; behavioral) designed to target sleep or pain for the duration of study participation exclusion criteria: 1. diagnosed with a sleep disorder 2. diagnosed with a pain disorder 3. has experienced a cold-related injury frostbite or has any other nerve damage to the feet 4. has a history of injury to any of the muscular measurement sites for pain (i.e. shoulder, jaw, forearm) 5. diagnosed with hypertension or cardiovascular disease 6. evidence of hypertension 7. diagnosed serious mental health disorder or substance use disorder 8. taking any physician-directed pharmacologic intervention for sleep 9. taking any physician-directed pharmacologic intervention for pain 10. personal health history of traumatic brain injury 11. pregnant 12. current smoker
a pilot trial of homeopathic treatment for attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit hyperactivity disorder (adhd) is a developmental disorder that presents during childhood, and is characterized by developmentally inappropriate levels of inattention and/or hyperactive-impulsive behavior. it is proposed that classical homeopathic treatment can reduce the symptoms of adhd without serious side effects. this is an open label pilot feasibility study (36 participants). participants, age 6-16, will consult with a homeopathic practitioner who will select treatments based on classical homeopathy principles. all participants will be assessed on a 4-weekly basis for a total of 36 weeks. the purpose of the study is to assess feasibility of recruitment and patient retention, to obtain pilot data on which to base a sample size calculation for future study, and to identify major safety concerns. the study will use single homeopathic medicines approved for over-the-counter use in canada. the primary outcome measure will be the validated conners 3rd edition - parent.


Eligibility criteria:
inclusion criteria: * males and females aged 6-16 diagnosed with adhd of any subtype according to dsm-iv criteria. * mentally competent participants able to adhere to the given protocol and treatments administered as interventions, and able to answer outcome measures. * primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study. exclusion criteria: * changes to participants' medication for adhd within 6 weeks of study onset. * diagnosis of additional mental health disorder including but not limited to: conduct disorder, autism spectrum disorder, bipolar disorder, and major depressive disorder. the patient should not have current suicidal or homicidal ideation. * participants should have no history of head injury of seizures, organ system damage and should have an estimated i.q within the normal range. * pregnancy and lactation

Keywords: attention deficit hyperactivity disorder attention deficit disorder adhd add homeopathy
a comparison of electrical pudendal nerve stimulation and transvaginal electrical stimulation for urge incontinence

Conditions: Urge Urinary Incontinence

Summary: the purpose of this study is to determine whether electrical pudendal nerve stimulation is more effective than transvaginal electrical stimulation in treating urge urinary incontinence (uui).

electrical neuromodulation can be used to treat uui refractory to medication. electrical neuromodulation therapies include transvaginal or transanal electrical stimulation (tes), percutaneous tibial nerve stimulation (ptns), sacral neuromodulation (snm), and pudendal neuromodulation (pnm). tes is easily applicable but is sometimes intolerable for many patients due to discomfort, mucosal injury, and high-intensity stimulation necessary to obtain acceptable outcome. snm with the interstim device differs from tes by its continuous stimulation and close nerve contact. it has a high rate of success, but symptoms appear to recur almost immediately after discontinuation of the stimulation, and at least 20 % of patients initially tested do not respond to a test procedure. its disadvantages included invasiveness, high cost of treatment, high surgical revision rate, device replacement required when battery runs out, and adverse events. pnm with the interstim device or the bion device can be used to treat uui refractory to snm, but this therapy also has the disadvantages similar to those of snm. ptns with needle electrodes is minimally invasive, demonstrates efficacy, and is easily applicable and well tolerated, but ptns effects diminish over time after the end of treatment. by combining the advantages of ptns and pnm and incorporating the technique of deep insertion of long acupuncture needles, the investigators developed electrical pudendal nerve stimulation (epns). in epns, long acupuncture needles of 0.40 х 100 or 125 mm were deeply inserted into four sacral points and electrified to stimulate the pudendal nerves (pn). ct transverse plane at the coccygeal apex has showed that the position of the lower needle tip is similar to where (adjacent to pn at alcock's canal) the bion device is implanted for chronic pn stimulation. besides the radiographic evidence, simultaneous records of perineal ultrasonographic pelvic floor muscle contraction, vaginal pressure and pelvic floor surface electromyogram in our previous study have proved that epns can exactly excite pn. the purpose of this study is to compare the efficacies of epns versus tes in treating female uui.

Eligibility criteria:
inclusion criteria: * uui history * positive pad test result * urodynamic study: a decrease in bladder capacity at the first desire for urination; a decrease in maximum bladder capacity; low compliance bladder exclusion criteria: * uui that can be relieved by drugs * neurogenic or non-neurogenic uui * other types of incontinence such as stress incontinence and overflow incontinence

Keywords: electrical pudendal nerve stimulation transvaginal electrical stimulation urge urinary incontinence comparative study
efficacy and safety study of ozanimod in relapsing multiple sclerosis

Conditions: Relapsing Multiple Sclerosis

Summary: this study is a two-part trial consisting of part a (see nct01628393) and part b, presented within this record. the primary objective of part b is to assess whether the clinical efficacy of ozanimod (rpc1063) is superior to interferon beta-1a (ifn β-1a; avonex®) in reducing the rate of clinical relapses at the end of month 24 in patients with relapsing multiple sclerosis (rms).

this clinical trial (rpc01-201; radiance) consisted of 2 parts, each reported separately on clinicaltrials.gov: part a (nct01628393) and part b (this record). part a was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as clinicaltrials.gov record nct01628393. part b, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. participants were allowed to enroll in the open-label extension study rpc01-3001 (nct02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Eligibility criteria:
inclusion criteria: * multiple sclerosis as diagnosed by the revised 2010 mcdonald criteria * expanded disability status scale (edss) score between 0 and 5.0 at baseline exclusion criteria: * primary progressive multiple sclerosis
syren study: a study of pegasys (peginterferon alfa-2a (40kd)) plus copegus (ribavirin) in non-responder patients with chronic hepatitis c (chc) genotype 1.

Conditions: Hepatitis C, Chronic

Summary: this study will evaluate the efficacy and safety of 4 regimens of pegasys plus copegus, in patients with chronic hepatitis c (chc) genotype 1 who have failed to respond to previous treatment with standard doses of pegasys plus ribavirin. patients will be randomized to one of 4 groups, to receive a)pegasys 360 micrograms/week plus copegus 1000-1200mg/day, b)pegasys 180 micrograms twice weekly plus copegus 1000-1200mg/day, c)pegasys 360micrograms/week plus copegus 1200-1600mg/day, or d)pegasys 180 micrograms twice weekly plus copegus 1200-1600mg/day. following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age, with chc genotype 1; * patients who have failed to respond to previous treatment with pegasys plus ribavirin for \>=12 weeks; * patients who have discontinued pegasys/ribavirin \>=4 weeks prior to enrollment; * compensated liver disease. exclusion criteria: * other forms of liver disease; * infection with hiv, hav, hbv; * hepatocellular cancer.
open-label efficacy and safety study of pozelimab in patients with cd55-deficient protein-losing enteropathy (chaple disease)

Conditions: CD55-deficient Protein-losing Enteropathy; CHAPLE

Summary: the primary objective of the study is to determine the effect of pozelimab on active cd55-deficient protein-losing enteropathy (ple; chaple). the secondary objectives of the study are: * to evaluate the safety and tolerability of pozelimab in patients with cd55-deficient ple disease * to evaluate the effect of pozelimab on cd55-deficient ple (both patients with active disease at baseline and those with inactive disease on eculizumab, switching to pozelimab) * to determine the effects of pozelimab on albumin and other serum proteins (total protein, immunoglobulins) * to determine the effects of pozelimab on ascites * to determine the effects of pozelimab on stool consistency * to determine the effect of pozelimab on health-related quality of life * to determine the effect of pozelimab on lab abnormalities observed in cd55-deficient ple such as hypertriglyceridemia, thrombocytosis, and hypovitaminosis b12 * to describe the effects of pozelimab on the sparing of concomitant medications and reduction in hospitalization days * to determine the effects of pozelimab on growth * to characterize the concentration of pozelimab in patients with cd55-deficient ple * to assess the incidence of treatment-emergent ada for pozelimab in patients with cd55-deficient ple disease


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of cd55-deficient ple/chaple disease (based on a history of ple), confirmed by biallelic cd55 loss-of-function mutation detected by genotype analysis * active disease as defined by the protocol or inactive disease on eculizumab therapy (and whose treating physician has the expectation of future access to renewed eculizumab treatment should this be required), and is willing to discontinue eculizumab during screening and start pozelimab at baseline with no eculizumab wash-out key exclusion criteria: * history of meningococcal infection * no documented meningococcal vaccination within 3 years prior to screening and patient unwilling to undergo vaccination during the study * no documented vaccination for haemophilus influenzae and streptococcus pneumoniae if applicable based on local practice or guidelines prior to screening and patient unwilling to undergo vaccination during the study if required per local practice or guidelines * presence of a concomitant disease that leads to hypoproteinemia at the time of starting pozelimab * a concomitant disease that leads to secondary intestinal lymphangiectasia such as a fontan procedure for congenital heart disease note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: cd55-deficient ple complement hyperactivation, angiopathic thrombosis, protein-losing enteropathy (chaple disease)
the effect of proton pump inhibition on palpitations

Conditions: Arrhythmia

Summary: feeling of palpitations with no clear arrhythmia is frequently encountered in clinical practice. the majority of these patients have documented sinus rhythm even while having symptoms. gastrointestinal association with such symptoms was first described by ludwig von roemheld (1871-1938).the investigators thought to investigate the effect of proton pump inhibition in patients with feeling of palpitations but no clear cause.

one hundred and fifty patients with palpitations and no clear cause for their symptoms will be randomized to receive either proton pump inhibitor (ppi) (lanzoprazole 30 mg) or placebo for one month. at base line they will be investigated to rule out arrhythmia by documenting normal heart rate (less than 110 beat per minute) or ecg showing normal sinus rhythm or mild sinus tachycardia (less than 110 per minute) during symptoms. obvious causes such as anxiety due to a stressful event or organic causes such anemia or thyroid disorders should be also ruled out. patient who agree to participate in the study will be asked to sign an informed consent. a baseline questionnaire with symptoms will be filled. they will then be randomized for treatment with either ppi or placebo once at night time. after 10 days of treatment they will be contacted and questioned regarding their symptoms. the two groups will be compared to see if there is any improvement of symptoms with treatment.

Eligibility criteria:
inclusion criteria: 1. persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included 2. clear causes that should be excluded are true arrhythmia such svt or vt or frequent premature atrial or ventricular contractions or any organic cause such as thyroid disorder, anemia (hg less than 11 g/dl) and obvious anxiety disorder 3. arrhythmia can be excluded by an ecg showing sinus rhythm or sinus tachycardia during episodes or measurement of heart rate by a reliable method during symptoms showing regular heart rate less than 120 beats per minute. exclusion criteria: 1. refusal to sign consent form 2. already taking ppi or h2 blocker 3. frequency of symptoms less than 2 times per week

Keywords: palpitations
cervical intraepithelial neoplasm (cin) in women (gardasil) (v501-015)

Conditions: Cervical Cancer; Genital Warts

Summary: the primary purpose of the study is to determine if gardasil™ (v501) is able to prevent cervical cancer.

in the 4-year base study (v501-015) (nct00092534), participants were randomized in a 1:1 order to receive 3 doses of gardasil™ or matching placebo at day 1, month 2, and month 6 and were assessed for efficacy, immunogenicity, and safety. in the base study extension (ext) \[v501-015-10\], participants who received placebo or only 1 dose of gardasil™ in the base study, were given 3 doses of open-label gardasil™ at ext day 1, ext month 2, and ext month 6, and were followed to ext month 7. participants who who received 2 doses of gardasil™ in the base study were given 1 dose of gardasil™ at ext day 1 and were followed for 15 days (day of vaccination plus 14 days). in the 10-year base study long-term follow-up (ltfu) \[v501-015-21\] the effectiveness, immunogenicity and safety of gardasil™ was assessed during a period of 10 years following completion of the base study (v501-015) \[14 years after the first dose of gardasil™\] and, for some measures, the base study ext (v501-015-10) \[10 years after the first dose of gardasil™\]. participants from denmark, iceland, norway and sweden who participated in the base study were eligible to enroll in the ltfu. effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately year 5 and year 10 of the v501-015-21 ltfu. an 8-year extension was added to the ltfu (v501-015-22\] to continue the evaluation of the long-term effectiveness and immunogenicity of gardasil™. effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately year 4 and year 8 of the extension of the ltfu.

Eligibility criteria:
inclusion criteria for the base study: * healthy women with an intact uterus with lifetime history of 0-4 sexual partners --for extension phase: * participant received placebo or an incomplete vaccination series in the original study --for ltfu: * participant was randomized into the base study from denmark, iceland, norway, or sweden. * agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from national registry study center and serum collection exclusion criteria for the base study: * prior human papilloma virus (hpv) vaccination * prior abnormal paps * prior history of genital warts --for extension phase: * prior complete hpv vaccination series * subject lives in a country in which gardasil is approved and is within the age range of the local labeling for gardasil --for ltfu study: * there were no exclusion criteria that did not overlap the inclusion criteria for this study.
an accessible digital intervention to promote hiv testing/counseling and prevention among adolescents

Conditions: HIV Prevention

Summary: this is phase ii of a study previously registered on clinicaltrials.gov (nct02812329). phase ii focuses on adapting and expanding the reach of a previously developed video game aimed at hiv prevention. the game will be adapted to include web access/distribution and be evaluated using a randomized controlled trial.

the specific aims for phase ii of this study are to: further adapt and expand our culturally and socially-tailored videogame to have a greater focus on hiv testing and counseling (htc) in addition to hiv prevention in an older age group of 14-18 year old boys and girls. this will be accomplished by refining the conceptual model of the theoretical mechanisms of behavior change to be applied specifically within the game. new content will be created with additional input from 4 focus groups of 5 adolescents each (n = 20, aged 14-18) and these participants will also play-test the game. in addition, this model will inform new intervention manuals ("game playbooks") targeting these new outcomes. building the new content from focus groups into the game are intended to adapt and expand its scope. a system will be established for the newly adapted game for web access/distribution and program integration. work will continue with commercialization partners on widespread distribution of the adapted game. the final piece of the study will be to conduct a randomized controlled trial in 296 adolescents (aged 14-18) to evaluate the acceptability and efficacy of the adapted game on its new web-based platform compared with a set of control games.

Eligibility criteria:
inclusion criteria: * ability to participate in a web-based videogame (willing to sit for 60 minutes/session to play the game) * have not been tested for hiv in the past year * ability to provide assent/parental/guardian consent+ * have a completed and signed enrollment form for their school's health clinic allowing them, if they choose, to access the clinic for testing and health care * students can be older than 18 as long as they were 18 or younger at the time of signing consent exclusion criteria: * failure to meet any of the eligibility criteria

Keywords: hiv testing and counseling (htc)
high dose chemotherapy in oligo-metastatic homologous recombination deficient breast cancer

Conditions: Breast Cancer

Summary: this study investigates the effect of high-dose alkylating chemotherapy compared with standard chemotherapy as part of a multimodality treatment approach in patients with oligo-metastatic breast cancer harboring homologous recombination deficiency.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed infiltrating breast cancer 2. oligometastatic disease defined as one to three distant metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the ipsilateral axillary, parasternal, and periclavicular regions. all lesions must be amenable to resection or radiotherapy with curative intent. staging examinations must have included a pet-ct-scan and a mri of the liver in case of liver metastases. clustered lymph nodes that can be irradiated with curative intent in a single field are defined as a single lesion. histologic or cytologic confirmation of at least one distant metastatic lesion is required. 3. no prior line of chemotherapy for metastatic disease (a maximum of 3 months of palliative endocrine therapy is allowed). 4. the tumor must be her2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry). 5. the tumor is deficient in homologous recombination and/or the patient has a deleterious germline brca1 or brca2 mutation. 6. at least stable disease of all tumor lesions after three courses of induction chemotherapy 7. age ≥18 years 8. world health organisation (who) performance status 0 or 1 9. adequate bone marrow function (anc ≥1.0 x 109/l, platelets ≥100 x 109/l) 10. adequate hepatic function (alat, asat and bilirubin ≤2.5 times upper limit of normal) 11. adequate renal function (creatinine clearance ≥60 ml/min) 12. if clinically recommended echocardiography, muga, or mri to evaluate if lvef ≥50%; 13. signed written informed consent 14. able to comply with the protocol exclusion criteria: * no malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy * no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection. * no concurrent anti-cancer treatment or investigational drugs

Keywords: oligo metastatic hrd deficiency